{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "190050",
      "product_res_number": "Z-0384-2022",
      "event_date_initiated": "2021-10-07",
      "event_date_created": "2021-12-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-10-23",
      "res_event_number": "88929",
      "product_code": "MUQ",
      "pma_numbers": [
        "P010003"
      ],
      "product_description": "BioGlue Surgical Adhesive, Model BG3510-5-G",
      "code_info": "Model BG3510-5-G, Lot BG000255",
      "firm_fei_number": "3001451326",
      "recalling_firm": "CryoLife, Inc.",
      "address_1": "1655 Roberts Blvd Nw",
      "city": "Kennesaw",
      "state": "GA",
      "postal_code": "30144-3632",
      "additional_info_contact": "770-419-3355",
      "reason_for_recall": "Product is not approved for use in the EU and should not have been distributed in the EU.",
      "root_cause_description": "No Marketing Application",
      "action": "A customer letter titled \"Urgent Field Safety Notice BioGlue\" was issued 10/07/2021 to  the impacted consignee.  All product is to be returned for final disposition.  A customer reply letter should be completed and submitted to the recalling firm.",
      "product_quantity": "156 5-pack box units",
      "distribution_pattern": "Distribution in the European Union only (Germany/Switzerland)",
      "openfda": {
        "pma_number": [
          "P010003"
        ],
        "registration_number": [
          "1058584",
          "1422634",
          "1047843",
          "1063481",
          "1450662",
          "1526611"
        ],
        "fei_number": [
          "1000514656",
          "3001451326",
          "1000219637",
          "1047843",
          "1450662",
          "1526611"
        ],
        "device_name": "Glue, Surgical, Arteries",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}